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510(k) Data Aggregation
K Number
K072534Device Name
BIO-MAT 2000
Manufacturer
RICHWAY INTL., INC.
Date Cleared
2008-02-08
(154 days)
Product Code
IRT
Regulation Number
890.5740Why did this record match?
Applicant Name (Manufacturer) :
RICHWAY INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.
Device Description
The Bio-Mat is an electrically powered mattress pad that applies infrared heat to the user's body for the temporary relief of minor body aches and pains. A control panel allows the user to turn the product on/off, modify the temperature, and set the product's timer.
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